Clinical Data Specialist

IQVIA; Bloemfontein; On-site; ZAR 300,000 - 600,000; Full time

Job summary

A leading global provider of clinical research services is seeking a Data Manager to perform comprehensive data management tasks, including data review and reconciliation. The role requires a Bachelor's degree in a Health or Science discipline, with mandatory data management experience. You will manage data streams, generate reports, and train staff while contributing to the success of clinical trials.

Qualifications

• Experience in clinical research and mandatory data management experience required.
• Ability to interpret clinical trial data and present trends.
• Experience working within diverse, cross-functional global teams.

Responsibilities

• Perform ongoing Data Reconciliation of all data streams.
• Create and provide status and metric reports.
• Train and mentor CDA staff.

Skills

GIS

Computer Data Entry

Facilities Management

ADMA

Fleet

Key Account

Education

Bachelor's degree in a Health or Science discipline

Tools

Microsoft Office

Job description

Perform comprehensive data management tasks including data review, query generation, and query resolution. This may also include, but is not limited to, creation of eCRF completion guidelines, entry of test data for eCRF, and Data Review Model testing of data validation rules. Data Management tasks should encompass Study Startup, Database Lock, and Closeout.

1. Perform ongoing Data Reconciliation of all data streams.
2. Attend study-related meetings and teleconferences.
3. Perform Study Closeout and Archiving Activities, including QC of subject and site archival CRFs.
4. Create and provide status and metric reports.
5. Generate reports on EDC and track cleaning progress.
6. Manage Freeze and lock of eCRF.
7. File documentation in the virtual Trial Master File (TMF).
8. Receive and enter lab normal ranges.

ADVANCED

1. Provide timely status updates, including issues and risks, to GDM and DMLs as needed.
2. Act as the Point of Contact for Global Data Manager / Clinical Data Manager, proactively identifying risks and providing mitigations.
3. Communicate with vendors to resolve reconciliation issues.
4. Contribute to Study setup activities, including creation of DVRs.
5. Create and/or provide inputs to Data Management documents (e.g., eCRF completion guidelines).
6. Review and provide inputs to Data Management documents (e.g., IRP, DMP).
7. Assign work to CDA staff on trials, coordinating with the Global Data Manager to understand priorities and timelines.
8. Assist the Data Management Leader in TMF compliance reviews.
9. Train and mentor CDA staff.

Education and Experience Guidelines

1. Bachelor's degree in a Health or Science discipline with experience in clinical research.
2. Mandatory Data Management experience and clinical trial work experience.
3. Experience working within diverse, cross-functional, global, multi-regional teams.
4. Knowledge of current industry standards (e.g., CDISC SDTM, CDASH) for Advanced CDA.
5. Knowledge of technology platforms and systems for data capture and processing.
6. Proficiency with Microsoft Office tools.
7. Highly organized with excellent written and verbal communication skills.
8. Ability to interpret clinical trial data and present trends to the clinical trial team.

Experience Level:

• Base level CDA: 13 years of experience.
• Advanced level CDA: >3 years of experience.

IQVIA is a leading global provider of clinical research services, commercial insights, and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at our website.

Required Experience: Unclear seniority.

Key Skills: GIS, Computer Data Entry, Facilities Management, ADMA, Fleet, Key Account.

Employment Type: Full-Time

Experience: Years

Vacancy: 1

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